Does The EU Allow Interchangeable Biosimilars?

The European Union and the United States have slightly different takes on biosimilars and interchangeability. The US sees biosimilars in two distinct forms: follow-on biosimilars that are expected to produce the same clinical result as the reference product, and “interchangeable” biosimilars that can be switched for the reference product.

So far, the FDA has not approved any biosimilars as interchangeable. The FDA released a draft guidance in January on what data needed to be submitted to support an application for an interchangeable biosimilar. When biosimilars are interchangeable, a pharmacist can switch the biologic for its biosimilar without notifying a doctor beforehand.

Even though the EU does not use the interchangeable designation like the US does, officials from the Finnish Medicines Agency, Netherlands’ Medicines Evaluation Board, the Norwegian Medicines Agency, and Germany’s Paul-Ehrlich-Institut all conclude that biosimilars licensed in the EU are interchangeable. The officials wrote an opinion piece in the BioDrugs publication outlining their thoughts on the matter in January.

Although biosimilars are unofficially interchangeable in the EU, there is still the need for interchangeability studies to be conducted. Officially, the region “has no plans to introduce new legal or regulatory requirements for interchangeability studies and thus create two classes of biosimilars.”




In today’s fast-growing, highly regulated generic pharmaceutical market, companies increasingly require specialized legal guidance as their products are developed, launched, and litigated. Wilson Sonsini Goodrich & Rosati’s attorneys address this need by providing expert counsel to companies in the global generics industry, offering sophisticated representation far beyond the scope of general corporate and securities counsel.

We have assembled a highly experienced team of experts from a cross-section of the firm’s key practice areas, including intellectual property, litigation, antitrust, FDA/regulatory, technology transactions, exports and FCPA, trade secret, and trademark and copyrights. Led by the former chief legal officer of Mylan Pharmaceuticals, one of the world’s leading generic and specialty pharmaceutical companies, our attorneys work closely with our generic pharmaceutical clients’ legal and scientific personnel and senior management to understand and meet their specific needs both in the U.S. and abroad.